Zero-fluoroscopic Navigation Versus Conventional Fluoroscopic Navigation for Double-chamber Pacemaker Implantation

Summary

This study is intended to compare the feasibility, safety and efficacy of Ensite-NavX zero-fluoroscopic navigation system to conventional fluoroscopic X-ray approach as to performing double-chamber pacemaker implantation.

Conditions

• Sick Sinus Syndrome
• Complete Atrioventricular Block
• High Degree Second Degree Atrioventricular Block (Disorder)
• Bradycardia

Interventions

PROCEDURE

zero-fluoroscopy 3D navigation

Pacemaker implantation will be performed without fluoroscopy using 3D navigation systems.

PROCEDURE

conventional x-ray navigation

Pacemaker implantation will be performed with fluoroscopy using conventional X-ray navigation.

Sponsors & Collaborators

• Fu Wai Hospital, Beijing, China

  collaborator OTHER

• Xinyang Central Hospital

  collaborator OTHER

• First Affiliated Hospital of Guangxi Medical University

  collaborator OTHER

• Guangdong Provincial People's Hospital

  collaborator OTHER

• Wuhan Asia Heart Hospital

  collaborator OTHER

• Shenzhen Sun Yat-sen Cardiovascular Hospital

  collaborator OTHER

• Ningbo No. 1 Hospital

  collaborator OTHER

• Tongji Hospital

  lead OTHER

Principal Investigators

• Yan Wang, PhD · Tongji Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-01-31

Primary Completion

2018-12-31

Completion

2020-12-31

Countries

• China

Study Locations